Compositions and methods for altering stool quality in an animal

ABSTRACT

The present invention provides compositions and methods for improving stool quality of a puppy by adjusting the balance of metabolizable cations to metabolizable anions consumed by the puppy.

The present invention relates generally to compositions and methods forimproving stool quality and/or stool frequency for an animal byadjusting the balance of metabolizable cations to metabolizable anionsconsumed by the animal.

BACKGROUND OF THE INVENTION

Stool quality and stool frequency are generally determined by fivefactors: food ingredient digestibility, fiber level, health status,activity level, and water intake. When these factors are balanced,stools are generally formed, firm, dark, and exhibit a relativelyreduced odor. Stools exhibiting these properties are considered to begood quality stools. If the factors are not balanced, stools aregenerally soft, loose, watery, light-colored, and exhibit a relativelyincreased odor. Stools exhibiting these properties, particularly loose,watery stools, are considered to be poor quality stools.

Poor stool quality and irregular stool frequency can be caused byvarious factors, e.g., abnormal intestinal motility, increases inintestinal permeability, the presence of nonabsorbable osmoticallyactive substances in the intestine, or agents that cause diarrhea.Similarly, some animal foods, particularly those known in the art aschunk and gravy animal foods, can cause poor stool quality. Often, ananimal consuming such foods has a fecal discharge that is irregular andundesirable. Such discharge is generally characterized by frequentloose, watery stools. In some instances, the discharge may be classifiedas diarrhea.

Accordingly, new methods and compositions are required which can affectstool quality of an animal. U.S. patent application Ser. No. 11/566,512(the '512 application) filed Dec. 4, 2006 (the contents of which areherein incorporated by reference) discloses adjusting the balance ofmetabolizable cations to metabolizable anions consumed by the animal toaffect stool quality. It has generally been found that increasing thebalance of metabolizable cations to metabolizable anions will result infirmer stool quality and reduced stool output. Conversely, decreasingthe balance of metabolizable cations to metabolizable anions will resultin looser stool and increased stool output.

While the '512 application describes methods for altering stool qualityand/or frequency for adult dogs, the dietary requirements of adult dogsand puppies are quite different. For example, puppies generallyexperience rapid growth and development; thus they generally requiresignificantly more nutrition than adult dogs and of a differentnutritional composition. For example, puppies require higher calciumlevels due to their rapid bone growth. Similarly, the stool of adultdogs and puppies are typically of different quality and it is known thata dog produces substantially firmer stool than a puppy, partly inresponse to their different diets and nutritional requirements. Thus,the cation and anion balance disclosed in the prior art, while suitablefor adult dogs, may be unsuitable for improving the stool quality of apuppy. The inventors of the present invention have discovered that thestool quality of a puppy may be improved by modifying the dietary cationand anion balance of a food composition consumed by the animal such thatthe dietary cation and anion balance is from about 50 to about 300 mEq.

SUMMARY OF THE INVENTION

It is one aspect of the present invention to provide compositions forimproving stool quality for an animal; particularly for a growing dog.In one embodiment, the present invention is a food compositioncomprising metabolizable cations and metabolizable anions, saidcomposition having a dietary cation to anion balance (DCAB) of fromabout 50 to about 300 mEq. The composition is ideally nutritionallycomplete for a puppy.

In additional embodiments, the composition may have a DCAB of from about75 to about 250 mEq, from about 100 to about 150 mEq, or have a DCAB ofabout 125 mEq.

In some embodiments the compositions of the present invention maycomprise cations chosen from calcium, sodium, potassium, magnesium, andmixtures thereof and may further comprise anions chosen from phosphorus,chloride, sulfur, and mixtures thereof.

In further embodiments, a composition of the present invention maycomprise potassium citrate in the amount of from about 0.5% to about1.0%, e.g., about 0.76%; and may further comprise sodium bicarbonate inan amount of from about 0.1% to about 0.5%, e.g., about 0.2%.

The compositions of the present invention may comprise soluble fiber inan amount of from about 1% to about 4%, e.g., about 3%. The solublefiber may be chosen from beet pulp, guar gum, chicory root, psyllium,pectin, blueberry, cranberry, squash, apples, oats, beans, citrus,barley, peas, or mixtures thereof.

In additional embodiments, the compositions of the present invention mayfurther comprise an omega-3 fatty acid in the amount of from about 0.1%to about 10%, e.g., about 0.18%. The omega-3 fatty acid may be chosenfrom DHA, EPA, ALA, octadecatetraenoic acid, and mixtures thereof.

The compositions disclosed herein may further comprise agastrointestinal tract-improving agent, an anti-diarrhea agent, ananti-constipation agent, or a mixture thereof.

In further embodiments, the compositions of the present invention may bein the form of a dry, wet or semi-moist food or a treat, snack,supplement or partially or fully edible toy.

Additional aspects of the invention relate to methods for improvingstool quality and/or stool frequency in a puppy. Thus, the presentinvention relates to a method for improving stool quality of a puppycomprising administering to the puppy a composition having a balance ofmetabolizable cations to metabolizable anions of from about 50 to about300 mEq.

Another aspect of the invention relates to a method to improve stoolquality of a puppy comprising increasing the dietary balance ofmetabolizable cations to metabolizable anions in the puppy. Inparticular embodiments, the balance of metabolizable cations tometabolizable anions may be increased by increasing the puppy's dietaryintake of a metabolizable cation, by decreasing the puppy's dietaryintake of a metabolizable anion or by both increasing the puppy'sdietary intake of metabolizable cations and decreasing the puppy'sdietary intake of metabolizable anions.

The invention also relates to a method for treating a puppy susceptibleto or suffering from constipation, comprising adjusting the balance ofmetabolizable cations to metabolizable anions consumed by the puppy byan amount sufficient to improve stool quality by decreasing the balanceof metabolizable cations to metabolizable anions consumed by the puppyto produce looser stool. In particular embodiments, the balance ofmetabolizable cations to metabolizable anions may be decreased bydecreasing the amount of metabolizable cations consumed by the puppy,increasing the amount of metabolizable anions consumed by the puppy orby both decreasing the amount of metabolizable cations and increasingthe amount of metabolizable anions consumed by the puppy.

The invention further relates to a method for treating a puppysusceptible to or suffering from diarrhea and/or loose stool, comprisingadjusting the balance of metabolizable cations to metabolizable anionsconsumed by the puppy by an amount sufficient to improve stool qualityby increasing the balance of metabolizable cations to metabolizableanions consumed by the puppy to produce firmer stool. In particularembodiments, the balance of metabolizable cations to metabolizableanions may be increased by increasing the amount of metabolizablecations consumed by the puppy, by decreasing the amount of metabolizableanions consumed by the puppy or by both increasing the amount ofmetabolizable cations and decreasing the amount of metabolizable anionsconsumed by the puppy.

In another aspect, the invention relates to a method for improving thestool quality of a puppy in need thereof comprising:

a. adding a sufficient amount of metabolizable cations or metabolizableanions to a food composition to increase or decrease the DCAB of thefood composition as desired;

b. administering the food composition of step (a) to the puppy;

c. evaluating the quality of stool produced by the puppy; and

d. repeating steps (a)-(c) until the puppy produces a stool havingdesired qualities.

In another aspect, the invention relates to a method for treating apuppy susceptible to or suffering from constipation by modifying thestool quality of the puppy comprising:

a. adding a sufficient amount of metabolizable anions to a foodcomposition to decrease the DCAB of the food composition;

b. administering the food composition of step (a) to the puppy;

c. evaluating the quality of stool produced by the puppy; and

d. repeating steps (a)-(c) until the puppy produces a stool havingdesired qualities.

In another embodiment, the invention relates to a method for treating apuppy susceptible to or suffering from diarrhea and/or loose stool bymodifying the stool quality of the puppy comprising:

a. adding a sufficient amount of metabolizable cations to the foodcomposition to increase the DCAB of the food composition;

b. administering the food composition of step (a) to the puppy;

c. evaluating the quality of stool produced by the puppy; and

d. repeating steps (a)-(c) until the puppy produces a stool havingdesired qualities.

With regard to any of the methods of the present invention, it iscontemplated herein that said methods may comprise the administration ofany of the compositions of the present invention, and may optionallyfurther comprise the administration to the puppy of at least onecompound chosen from one or more gastrointestinal tract-improvingagents, and/or one or more anti-diarrhea agents and/or one or moreanti-constipation agents. Furthermore, the metabolizable cations mayinclude those chosen from calcium, sodium, potassium, magnesium, andmixtures thereof and pharmaceutically acceptable salts thereof. Themetabolizable anions may include those chosen from phosphorus, chloride,sulfur, and mixtures thereof and pharmaceutically acceptable saltsthereof.

In another embodiment the present invention relates to kits for alteringstool quality of a puppy comprising any one or more of the followingcomponents:

a nutritionally complete puppy food composition;

metabolizable cations;

metabolizable anions;

a gastrointestinal tract-improving agent, an anti-diarrhea agent and/oran anti-constipation agent; and

instructions for altering the stool quality of a puppy by increasing ordecreasing the DCAB of the food composition using metabolizable anionsand/or metabolizable cations to modify stool quality depending on thecondition of stool of a puppy to be treated, optionally with or withoutthe additional use of a gastrointestinal tract-improving agent, ananti-diarrhea agent and/or an anti-constipation agent.

In another embodiment, the present invention is directed to the use ofmetabolizable anions and metabolizable cations in the manufacture of afood composition to alter stool quality in a puppy in need thereof andwherein said food composition has a DCAB from about 50 to about 300 mEq.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is specifically directed to improving puppy stoolquality. It is contemplated herein, however, that the compositions andmethods disclosed herein may be used with any animal, especially agrowing animal, particularly a growing companion animal. The term“companion animal” refers to any animal that lives in close associationwith humans and includes, but is not limited to, canines and felines ofany breed. For example, it is contemplated herein that this term mayalso encompass any animal whose diet may be controlled by humans andwhich may benefit from methods and feeding the compositions disclosedherein. These animals may include, for example, domesticated farmanimals (e.g. cattle, horses, swine, etc.) as well as undomesticatedanimals held in captivity, e.g. in zoological parks and the like.

An animal is “susceptible to” a disease or condition if the animalexhibits symptoms that indicate that the animal is likely to develop thecondition or disease. An animal is “suffering from” a disease orcondition if the animal exhibits symptoms that are indicative that theanimal has developed the condition or disease.

As used herein, the term “puppy” refers to an immature canine, typicallybetween the ages of birth and 12 months.

As used herein, “altering stool quality”, “modifying stool quality” or“improving stool quality” refers to modifying the stool of an animal toproduce a desired firmness in the stool and/or a desired stoolfrequency. Generally, stools that are loose and watery are not desired,nor are stools that are so firm that constipation is observed. Thus,stool quality is improved in an animal experiencing diarrhea (e.g.,frequent loose, watery stools) by causing the stool to be more firm andcausing the animal to produce fewer stools; conversely, an animalexperiencing constipation will benefit by a change in stool quality suchthat the stool is less firm. As described herein, such changes maybeachieved by altering the animal's dietary cation-anion balance (DCAB).An increase in DCAB can cause stool to be firmer; a decrease in DCAB cancause stool to be less firm.

Stool quality may be scored according to methods familiar to one ofskill in the art. For example, fecal quality is commonly assessed bythose of skill in the art by visual scoring, e.g., ranking stoolvisually on a scale from grade 1-5 as follows:

-   -   Grade1: Greater than two-thirds of the feces in a defecation are        liquid. The feces have lost all form, appearing as a puddle or        squirt.    -   Grade 2: Soft-liquid feces are an intermediate between soft and        liquid feces. Approximately equal amounts of feces in a        defecation are soft and liquid.    -   Grade 3: Greater than two-thirds of the feces in a defecation        are soft. The feces retain enough form to pile but have lost        their firm cylindrical appearance.    -   Grade 4: Firm-soft feces are an intermediate between the grades        of firm and soft. Approximately equal amounts of feces in a        defecation are firm and soft.    -   Grade 5: Greater than two-thirds of the feces in a defecation        are firm. They have a cylindrical shape with little flattening.        See also, Sunvold et al., J Anim Sci 1995 73:1099-1109; U.S.        Pat. No. 6,280,779; U.S. Pat. No. 5,616,569. Stool quality may        also be assessed quantitatively using methods to determine the        amount of moisture in the feces in g/kg (see, e.g., Yamka et        al., 2006, Am J Vet Res, 67(1):88-94).

The balance of metabolizable cations to metabolizable anions in thepresent invention can be determined by any means known to skilledartisans. For example, one method for measuring the balance ofmetabolizable cations to metabolizable anions is to calculate theanimal's dietary cation-anion balance (DCAB), which is determined bycalculating the cumulative amount of cations regularly consumed by theanimal and subtracting the cumulative amount of anions consumed by theanimal. Cations may include, e.g., sodium, potassium, calcium, andmagnesium cations, or any other ion having a positive charge, includingamino acids. Anions may include, e.g., chloride, sulfur, and phosphorusanions, or any other ion having a negative charge, including aminoacids. For example, the DCAB is determined by calculating the cumulativeamounts of sodium, potassium, calcium, and magnesium cations regularlyconsumed by the animal and subtracting the cumulative amount ofchloride, sulfur, and phosphorus anions regularly consumed by theanimal. Thus, in one embodiment, the DCAB is determined in accordancewith the following equation:

DCAB (mEq)=(Na+K+Ca+Mg)−(Cl+S+P)

For purposes of calculating the DCAB, sodium, potassium and chlorideions have a balance of 1, sulfur, calcium and magnesium ions have abalance of 2, and phosphorus ions have a balance of 1.8.

The inventors of the present invention have discovered that the stoolquality of an animal, specifically, a growing dog, e.g., a puppy, can beimproved by feeding the animal a composition having a DCAB of from about50 to about 300 mEq.

As known in the art, a puppy's stool quality (i.e., an increase in stoolfirmness) may typically be increased by increasing the amount of solublefiber in the diet. Similarly, a puppy's stool quality is typicallydecreased by decreasing the amount of soluble fiber in the diet. Solublefibers are fibers which are resistant to digestion and absorption in thesmall intestine and undergo complete or partial fermentation in thelarge intestine, e.g., beet pulp, guar gum, chicory root, psyllium,pectin, blueberry, cranberry, squash, apples, oats, beans, citrus,barley, or peas. Significantly, the inventors of the present inventionhave found that the soluble fiber content of a food composition may bedecreased while still maintaining the stool quality of a puppy byincreasing the DCAB of the food composition.

In some embodiments, the balance of metabolizable cations tometabolizable anions consumed by the animal can be adjusted inconjunction with the administration of one or more anti-diarrhea agents(to treat or prevent diarrhea or overly loose stool) oranti-constipation agents (to treat or prevent constipation or overlyfirm stool). The term “anti-diarrhea agent” means any compound,composition, or drug useful for preventing or treating diarrhea, whichare known by those of skill in the art. Examples of these agentsinclude, but are not limited to, compounds such as atropine,diphenoxylate, loperamide, octreotide, and opium tinctures. The term“anti-constipation agent” means any compound, composition, or druguseful for preventing or treating constipation which are known by thoseof skill in the art. Such compounds include laxatives, e.g., psyllium,methylcellulose, docusate, mineral oil, milk of magnesia, and Epsomsalts. Appropriate anti-diarrhea and anti-constipation agents, andamounts thereof for use with companion animals are familiar to one ofskill in the art.

As contemplated herein, the compositions of the present invention aremeant to encompass nutritionally complete and balanced pet foodcompositions (also referred to herein simply as “nutritionally completepet food compositions”). Nutritionally complete pet food compositions,including nutritionally complete puppy foods, are familiar to one ofskill in the art. For example, nutrients and ingredients such as thosedisclosed herein as well as others suitable for animal feedcompositions, and recommended amounts thereof, may be found, forexample, in the Official Publication of the Associate of American FeedControl Officials (“AAFCO”), Inc., Nutrient Requirements of Dogs andCats, 2006. For example, nutritionally complete foods may containprotein, fat, carbohydrate, dietary fiber, amino acids, minerals,vitamins, and other ingredients in amounts known by those of skill inthe art.

Protein may be supplied by any of a variety of sources known by thoseskilled in the art, including plant sources, animal sources, or both.Animal sources include, for example, meat, meat by-products, seafood,dairy, eggs, etc. Meats include, for example, the flesh of poultry,fish, and mammals (e.g., cattle, pigs, sheep, goats, and the like). Meatby-products include, for example, lungs, kidneys, brain, livers, andstomachs and intestines (freed of all or essentially all theircontents). The protein can be intact, almost completely hydrolyzed, orpartially hydrolyzed.

Fat can be supplied by any of a variety of sources known by thoseskilled in the art, including meat, meat by-products, fish oil, andplants. Plant fat sources include wheat, flaxseed, rye, barley, rice,sorghum, corn, oats, millet, wheat germ, corn germ, soybeans, peanuts,and cottonseed, as well as oils derived from these and other plant fatsources.

Carbohydrate may be supplied by any of a variety of sources known bythose skilled in the art, including oat fiber, cellulose, peanut hulls,beet pulp, parboiled rice, corn starch, corn gluten meal, and anycombination of those sources. Grains supplying carbohydrate include, butare not limited to, wheat, corn, barley, and rice. Carbohydrate contentof foods may be determined by any number of methods known by those ofskill in the art. Generally, carbohydrate percentage may be calculatedas nitrogen free extract (“NFE”), which may be calculated as follows:NFE=100%−moisture %−protein %−fat %−ash %−crude fiber %.

Fatty acids for inclusion in the compositions of the present inventioninclude omega 3 fatty acids such as docosahexanenoic acid (DHA),eicosapentaenoic acid (EPA), alpha-linolenic acid (ALA),octadecatetraenoic acid (stearidonic acid) or mixtures thereof.

Dietary fiber refers to components of a plant which are resistant todigestion by an animal's digestive enzymes. Dietary fiber includessoluble and insoluble fibers. Soluble fiber are resistant to digestionand absorption in the small intestine and undergo complete or partialfermentation in the large intestine, e.g., beet pulp, guar gum, chicoryroot, psyllium, pectin, blueberry, cranberry, squash, apples, oats,beans, citrus, barley, or peas. Insoluble fiber may be supplied by anyof a variety of sources, including cellulose, whole wheat products,wheat oat, corn bran, flax seed, grapes, celery, green beans,cauliflower, potato skins, fruit skins, vegetable skins, peanut hulls,and soy fiber. Crude fiber includes indigestible components contained incell walls and cell contents of plants such as grains, e.g., hulls ofgrains such as rice, corn, and beans.

Amino acids, including essential amino acids, may be added to thecompositions of the present invention as free amino acids, or suppliedby any number of sources, e.g., crude protein, to the compositions ofthe present invention. Essential amino acids are amino acids that cannotbe synthesized de novo, or in sufficient quantities by an organism andthus must be supplied in the diet. Essential amino acids vary fromspecies to species, depending upon the organism's metabolism. Forexample, it is generally understood that the essential amino acids fordogs and cats (and humans) are phenylalanine, leucine, methionine,lysine, isoleucine, valine, threonine, tryptophan, histidine andarginine. In addition, taurine, while technically not an amino acid buta derivative of cysteine, is an essential nutrient for cats.

The compositions of the present invention may also contain one or moreminerals and/or trace elements, e.g., calcium, phosphorus, sodium,potassium, magnesium, manganese, copper, zinc, choline, or iron salts,in amounts required to avoid deficiency and maintain health. Theseamounts are known by those of skill in the art, for example, as providedin the Official Publication of the Associate of American Feed ControlOfficials, Inc. (“AAFCO”), Nutrient Requirements of Dogs and Cats, 2006.

The compositions of the present invention may also include vitamins inamounts required to avoid deficiency and maintain health. These amounts,and methods of measurement are known by those skilled in the art. Forexample, the Official Publication of the Associate of American FeedControl Officials, Inc. (“AAFCO”), Nutrient Requirements of Dogs andCats, 2006 provides recommended amounts of such ingredients for dogs andcats. As contemplated herein, useful vitamins may include, but are notlimited to, vitamin A, vitamin B₁, vitamin B₂, vitamin B₆, vitamin B₁₂,vitamin C, vitamin D, vitamin E, vitamin H (biotin), vitamin K, folicacid, inositol, niacin, and pantothenic acid.

The compositions of the present invention may additionally compriseadditives, stabilizers, fillers, thickeners, flavorants, palatabilityenhancers and colorants in amounts and combinations familiar to one ofskill in the art.

In one embodiment, the compositions of the present invention areprovided as a food, e.g., a nutritionally complete pet food composition.In another embodiment, the compositions of the present invention may bein the form of a treat, snack, supplement, or partially or fully edibletoy. Such items for consumption by a pet are known to those skilled inthe art, and can include, for example, compositions that are given to ananimal to eat during non-meal time, e.g., a dog biscuits, edible chewtoys, etc.

Foods of any consistency or moisture content are contemplated, e.g., thecompositions of the present invention may be, for example, a dry, moistor semi-moist animal food composition. “Semi-moist” refers to a foodcomposition containing from about 25 to about 35% moisture. “Moist” foodrefers to a food composition that has a moisture content of about 60 to90% or greater. “Dry” food refers to a food composition with about 3 toabout 11% moisture content and is often manufactured in the form ofsmall bits or kibbles. Also contemplated herein are compositions thatmay comprise components of various consistency as well as componentsthat may include more than one consistency, for example, soft, chewymeat-like particles as well as kibble having an outer cereal componentand an inner cream component as described in, e.g., U.S. Pat. No.6,517,877. The kibble may then be dried and optionally coated with oneor more topical coatings known by those skilled in the art, for example,flavors, fats, oils, powders, and the like.

In addition to the optional use of anti-diarrhea agents andanti-constipation agents in the methods of the present invention, insome embodiments, the balance of metabolizable cations to metabolizableanions consumed by the animal can be adjusted in conjunction with theadministration of one or more compositions comprising a gastrointestinaltract-improving agent. “Gastrointestinal tract-improving agents” aregenerally probiotics and prebiotics.

Probiotics are live microorganisms that have a beneficial effect in theprevention and treatment of specific medical conditions when ingested.Probiotics are believed to exert biological effects through a phenomenonknown as colonization resistance. The probiotics facilitate a processwhereby the indigenous anaerobic flora limits the concentration ofpotentially harmful (mostly aerobic) bacteria in the digestive tract.Other modes of action, such as supplying enzymes or influencing enzymeactivity in the gastrointestinal tract, may also account for some of theother functions that have been attributed to probiotics. Probiotics mayenhance an animals systemic cellular immune responses and may be usefulas a dietary supplement to boost natural immunity in otherwise healthyanimals. Probiotics include many types of bacteria but generally arechosen from four genera of bacteria: Lactobacilllus acidophillus,Bifidobacteria, Lactococcus, and Pediococcus.

Prebiotics are nondigestible food ingredients that beneficially affecthost health by selectively stimulating the growth and/or activity ofbacteria in the colon, and are known by those of skill in the art. Forexample, fructooligosaccharide (FOS) is found naturally in many foodssuch as wheat, onions, bananas, honey, garlic, and leeks. FOS can alsobe isolated from chicory root or synthesized enzymatically from sucrose.FOS fermentation in the colon results in a large number of physiologiceffects including increasing the numbers of bifidobacteria in the colon,increasing calcium absorption, increasing fecal weight, shortening ofgastrointestinal transit time, and possibly lowering blood lipid levels.The increase in bifidobacteria has been assumed to benefit health byproducing compounds to inhibit potential pathogens, by reducing bloodammonia levels, and by producing vitamins and digestive enzymes.Probiotic bacteria Such as Lactobacilli or Bifidobacteria are believedto positively affect the immune response by improving the intestinalmicrobial balance leading to enhanced antibody production and phagocyticactivity of white blood cells.

The amount of probiotics and prebiotics to be administered to the animalis determined by the skilled artisan based upon the type and nature ofthe probiotic and prebiotic and the type and nature of the animal, e.g.,the age, weight, general health, sex, extent of microbial depletion,presence of harmful bacteria, and diet of the animal. Generally,probiotics are administered to the animal in amounts of from about oneto about twenty billion colony forming units (CFUs) per day for thehealthy maintenance of intestinal microflora, preferably from about 5billion to about 10 billion live bacteria per day. Generally, prebioticsare administered in amounts sufficient to positively stimulate thehealthy microflora in the gut and cause these “good” bacteria toreproduce. Typical amounts are from about one to about 10 grams perserving or from about 5 percent to about 40 percent of the recommendeddaily dietary fiber for an animal.

In another embodiment, the present invention provides kits suitable forimproving stool quality and/or stool frequency for an animal. Said kitsmay comprise combinations of cations, anions, foods, other compounds,agents or medicaments, and instructions for using said kit componentsfor improving stool quality and/or stool frequency for an animal in needthereof. For example, it is contemplated that kits of the presentinvention may comprise metabolizable cations chosen from calcium,sodium, potassium, magnesium, and mixtures thereof; metabolizable anionsmay be chosen from phosphorus, chloride, sulfur, and mixtures thereof.Any and all forms of said metabolizable cations and anions arecontemplated, including pharmaceutically acceptable salt forms. Thecomponents of the kits may further comprise a gastrointestinaltract-improving agent, an anti-diarrhea agent and/or ananti-constipation agents and instructions for use thereof.

For example, a kit may comprise a nutritionally complete food, e.g., apuppy food in addition to a metabolizable cation, and/or a metabolizableanion with instructions regarding how to increase the DCAB of the foodcomposition with the metabolizable cation and/or instructions as to howto decrease the DCAB of the food composition with metabolizable anionsin order to achieve a desired improvement in stool quality in an animalin need thereof. In some embodiments, the kit may further comprises oneor more anti-diarrhea agents, anti-constipation agents, and/orgastrointestinal tract-improving agents and instructions for use thereofwith the food and metabolizable cations and anions. It is understoodthat addition of cations will cause the stool to be more firm; theaddition of anions will cause the stool to be less firm. Based on theteachings of the present invention, one of skill in the art willunderstand how to modify the DCAB in the animal depending on thecondition of the stool of the animal to be treated and the change instool firmness desired.

The kit components may exist in a single package or separate packages asappropriate for the kit component. The term “single package” generallymeans that the components of a kit are physically associated in or withone or more containers and considered as a unit of manufacture,distribution, sale, or use. Containers include, but are not limited to,bags, boxes, bottles, shrink wrap packages, stapled or otherwise fixedcomponents, or combinations thereof. A single package can be, forexample, containers or individual food compositions physicallyassociated such that they are considered a unit for manufacture,distribution, sale, or use.

In another embodiment, the present invention is directed to the use ofmetabolizable anions and metabolizable cations in the manufacture of afood composition to alter stool quality in an animal in need thereof,and wherein said food composition has a DCAB of from about 50 to about300 mEq.

EXAMPLES

This invention can be further illustrated by the following examples,although it will be understood that the examples are included merely forpurposes of illustration and are not intended to limit the scope of theinvention unless otherwise specifically indicated.

Example 1

Ten weaned beagle puppies are used in stool studies to determine 1) ifthe DHA upgrade effects stool quality in puppies, 2) if stool qualitycan be improved through manipulation of dietary cation anion balance(DCAB) in puppies and 3) what effects decreasing levels of beet pulp inconjunction with DCAB manipulation have on puppy stool quality. Thenutrient compositions of each food treatment are presented in Table 1.Each food is kibbled and formulated in accordance with AAFCO standardsfamiliar to one of skill in the art (e.g., as may be found in AAFCO'snutrient guides for dogs and cats) and balanced to meet growing puppyrequirements. Each food is fed for a period of one week and stool scoresare recorded daily. Each stool sample is scored on a grading scale of 1to 5 according to conventional methods as described hereinabove, whereingrade 1 reflects stool wherein greater than two-thirds of the feces areliquid, and grade 5 reflects stool wherein greater than two-thirds ofthe feces are firm.

TABLE 1 Analyzed Nutrient Composition of Foods Fed to Dogs^(a)Ingredient Food A Food B Food C Food D Food E Food F Food G CrudeProtein, % 29.30 31.75 31.85 31.81 31.85 31.89 30.19 Crude Fat, % 19.6219.95 20.01 19.96 20.01 20.02 20.41 Calcium, % 1.49 1.48 1.47 1.49 1.471.46 1.41 Phosphorous, % 1.23 1.20 1.21 1.20 1.21 1.22 1.22 Sodium, %0.50 0.50 0.50 0.45 0.45 0.50 0.50 Magnesium, % 0.13 0.13 0.13 0.13 0.120.12 0.13 Chloride, % 1.09 1.09 1.09 0.55 0.55 0.56 0.72 Sulfur, % 0.370.40 0.39 0.40 0.39 0.39 0.37 Potassium, % 0.77 0.80 0.80 0.72 0.72 0.720.73 Essential Fatty Acids, % 4.24 4.78 4.82 4.78 4.82 4.80 4.67 DHA, %0.02 0.18 0.18 0.18 0.18 0.18 0.18 Beet Pulp 5.50 5.50 3.00 5.50 3.00 —5.50 DCAB^(b) 8.5 16.5 3.7 126.2 113 102.3 87.3 Average Age of dogs(years) 0.256 0.276 0.292 0.312 0.332 0.352 0.386 Stool Score^(c) 4.074.03 3.78 4.24 4.56 4.19 4.30 Stool Count^(d) 58 35 46 71 82 89 67^(a)on Dry Matter Basis ^(b)DCAB (mEq) = (Sodium + Potassium + Calcium +Magnesium) − (Chloride + Sulfur + Phosphorous) ^(c)Stool scores wereranked from 1 to 5 according to conventional methods as described intext. ^(d)Number of stools scored over seven-day period

The results described in Table 1 indicate that increasing the DCAB offood compositions can cause the production of better quality (firmer)stool, even though amounts of soluble fiber are decreased. Specifically,the highest stool quality in puppies is achieved when beet pulp islowered to 3.0% (from 5.5%) and DCAB is increased. Results also indicatethat potassium chloride maybe replaced by potassium citrate and sodiumchloride may be replaced by sodium bicarbonate in the food compositions(data not shown).

Example 2

An additional study with the same 10 beagle puppies at an older age isrepeated with Foods A, B, and E. Data for this study (including theaverage ages and weights of the dogs in the studies described inExample 1) are provided in Table 2. Data in the study using the olderdogs confirm the results of Example 1.

TABLE 2 Stool Score, Stool Count, and Average Age and Weight for PuppiesFood A Food B Food C Food D EXAMPLE 1 Average Age, years 0.256 0.2760.292 0.312 Average Body Weight, kg 5.125 5.181 5.136 5.502 Stool Score4.07 4.03 3.78 4.24 Stool Count 58 35 46 71 EXAMPLE 2 Average Age, years0.406 0.426 — — Average Body Weight, kg 6.791 6.977 — — Stool Score 4.304.50 — — Stool Count 73 82 — — Food E Food F Food G EXAMPLE 1 AverageAge, years 0.332 0.352 0.386 Average Body Weight, kg 6.151* 5.773 6.655Stool Score 4.56 4.19 4.30 Stool Count 82 89 67 EXAMPLE 2 Average Age,years 0.446 — — Average Body Weight, kg 7.063 — — Stool Score 4.72 — —Stool Count 61 — — *One animal was not included in the average bodyweight calculation because of no available data.

In the specification, there have been disclosed typical embodiments ofthe invention and, although specific terms are employed, they are usedin a generic and descriptive sense only and not for purposes oflimitation. Obviously many modifications and variations of the inventionare possible in light of the above teachings. It is therefore to beunderstood that the invention may be practiced otherwise than asspecifically described.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural reference unless the context clearly indicatesotherwise. The terms “comprise”, “comprises”, and “comprising” are to beinterpreted inclusively rather than exclusively.

Unless defined otherwise, all technical and scientific terms and anyacronyms used herein have the same meanings as commonly understood byone of ordinary skill in the art in the field of this invention. Allpatents, patent applications, publications, and other references citedor referred to herein are incorporated by reference in their entiretyfor all purposes.

1. A food composition comprising metabolizable cations and metabolizableanions, said composition having a dietary cation to anion balance (DCAB)of from about 50 to about 300 mEq.
 2. The food composition of claim 1which is a nutritionally complete food composition.
 3. The foodcomposition of claim 1 having a DCAB of from about 75 to about 250 mEq.4. The food composition of claim 1 having a DCAB of from about 100 toabout 150 mEq.
 5. The food composition of claim 1 having a DCAB of about125 mEq.
 6. The food composition of claim 1 wherein said metabolizablecations are chosen from calcium, sodium, potassium, magnesium, andmixtures thereof.
 7. The food composition of claim 1 wherein saidmetabolizable anions are chosen from phosphorus, chloride, sulfur, andmixtures thereof.
 8. The food composition of claim 1 comprisingpotassium citrate in the amount of from about 0.5% to about 1.0%.
 9. Thefood composition of claim 1 comprising potassium citrate in the amountof about 0.76%.
 10. The food composition of claim 1 comprising sodiumbicarbonate in an amount of from about 0.1% to about 0.5%.
 11. The foodcomposition of claim 1 comprising sodium bicarbonate in an amount ofabout 0.2%.
 12. The food composition of claim 1 comprising a solublefiber in the amount of from about 1% to about 4%.
 13. The foodcomposition of claim 1 comprising 3% soluble fiber.
 14. The foodcomposition of claim 1 comprising a soluble fiber chosen from beet pulp,guar gum, chicory root, psyllium, pectin, blueberry, cranberry, squash,apples, oats, beans, citrus, barley, peas, or mixtures thereof.
 15. Thefood composition of claim 1 comprising 3% beet pulp.
 16. The foodcomposition of claim 1 comprising an omega-3 fatty acid in the amount offrom about 0.1% to about 10%.
 17. The food composition of claim 1comprising about 1.8% omega -3 fatty acid.
 18. The food composition ofclaim 1 comprising omega-3 fatty acid chosen from DHA, EPA, ALA,octadecatetraenoic acid, and mixtures thereof.
 19. The food compositionof claim 1 comprising a gastrointestinal tract-improving agent, and/oran anti-diarrhea agent, and/or an anti-constipation agent, or a mixturethereof.
 20. The food composition of claim 1 wherein the foodcomposition is a dry food.
 21. The food composition of claim 1 whereinthe food composition is a moist food.
 22. The food composition of claim1 wherein the food composition is a semi-moist food.
 23. The foodcomposition of claim 1 where the food composition is in the form of atreat, snack, supplement or partially or fully edible toy.
 24. A methodfor improving stool quality and/or stool frequency of a puppy comprisingadministering to the puppy a composition having a balance ofmetabolizable cations to metabolizable anions of from about 50 to about300 mEq.
 25. A method to improve stool quality and/or stool frequency ofa puppy comprising increasing the dietary balance of metabolizablecations to metabolizable anions for the puppy.
 26. The method of claim25 wherein the balance is increased by increasing the puppy's dietaryintake of a metabolizable cation.
 27. The method of claim 25 wherein thebalance is increased by decreasing the puppy's dietary intake of ananion.
 28. The method of claim 25 wherein the balance is increased byincreasing the puppy's dietary intake of a metabolizable cation and bydecreasing the puppy's dietary intake of a metabolizable anion.
 29. Themethod of claim 24 or 25 wherein the metabolizable anions are chosenfrom phosphorus, chloride, sulfur, and mixtures thereof.
 30. The methodof claim 24 or 25 wherein the metabolizable cations are chosen fromcalcium, sodium, potassium, magnesium, and mixtures thereof.
 31. Themethod of claim 24 or 25 comprising administering to the puppy at leastone compound chosen from one or more gastrointestinal tract-improvingagents and/or one or more anti-diarrhea agents.
 32. A method fortreating a puppy susceptible to or suffering from constipation,comprising adjusting the balance of metabolizable cations tometabolizable anions consumed by the puppy by an amount sufficient toimprove stool quality by decreasing the balance of metabolizable cationsto metabolizable anions consumed by the puppy to produce looser stool.33. The method of claim 32 wherein the balance of metabolizable cationsto metabolizable anions is decreased by decreasing the amount ofmetabolizable cations consumed by the puppy.
 34. The method of claim 32wherein the balance of metabolizable cations to metabolizable anions isdecreased by increasing the amount of metabolizable anions consumed bythe puppy.
 35. The method of claim 32 wherein the balance ofmetabolizable cations to metabolizable anions is decreased by decreasingthe amount of metabolizable cations and increasing the amount ofmetabolizable anions consumed by the puppy.
 36. A method for treating apuppy susceptible to or suffering from diarrhea and/or loose stool,comprising adjusting the balance of metabolizable cations tometabolizable anions consumed by the puppy by an amount sufficient toimprove stool quality by increasing the balance of metabolizable cationsto metabolizable anions consumed by the puppy to produce firmer stool.37. The method of claim 36 wherein the balance of metabolizable cationsto metabolizable anions is increased by increasing the amount ofmetabolizable cations consumed by the puppy.
 38. The method of claim 36wherein the balance of metabolizable cations to metabolizable anions isincreased by decreasing the amount of metabolizable anions consumed bythe puppy.
 39. The method of claim 36 wherein the balance ofmetabolizable cations to metabolizable anions is increased by increasingthe amount of metabolizable cations and decreasing the amount ofmetabolizable anions consumed by the puppy.
 40. A method for improvingthe stool quality of a puppy in need thereof comprising a. adding asufficient amount of metabolizable cations or metabolizable anions to afood composition to increase or decrease the DCAB of the foodcomposition as desired; b. administering the food composition of step(a) to the puppy; c. evaluating the quality of stool produced by thepuppy; and d. repeating steps (a)-(c) until the puppy produces a stoolhaving desired qualities.
 41. A method for treating a puppy susceptibleto or suffering from constipation by modifying the stool quality of thepuppy comprising: a. adding a sufficient amount of metabolizable anionsto a food composition to decrease the DCAB of the food composition; b.administering the food composition of step (a) to the puppy; c.evaluating the quality of stool produced by the puppy; and d. repeatingsteps (a)-(c) until the puppy produces a stool having desired qualities.42. A method for treating a puppy susceptible to or suffering fromdiarrhea and/or loose stool by modifying the stool quality of the puppycomprising: a. adding a sufficient amount of metabolizable cations to afood composition to increase the DCAB of the food composition; b.administering the food composition of step (a) to the puppy; c.evaluating the quality of stool produced by the puppy; and d. repeatingsteps (a)-(c) until the puppy produces a stool having desired qualities.43. A kit for altering stool quality of a puppy comprising any one ormore of: a nutritionally complete puppy food composition; metabolizablecations; metabolizable anions; a gastrointestinal tract-improving agent,an anti-diarrhea agent, and/or an anti-constipation agent; andinstructions for altering the stool quality of a puppy by increasing ordecreasing the DCAB of the food composition using metabolizable anionsand/or metabolizable cations to modify stool quality depending on thecondition of the stool of a puppy to be treated.
 44. The kit of claim 43wherein said metabolizable cations are chosen from calcium, sodium,potassium, magnesium, and mixtures thereof in pharmaceuticallyacceptable salt form.
 45. The kit of claim 43 wherein said metabolizableanions are chosen from phosphorus, chloride, sulfur, and mixturesthereof in pharmaceutically acceptable salt form.